In women, the normal menstrual cycle is characterized by numerous neuroendocrine and physiologic changes. In addition to hormonal variations, body weight and basal metabolic rate increase during the luteal phase, and reliable although complex differences among cycle phases have been found in brain electrical activity and sensory function. However, clinical observation and controlled studies continue to find that psychologic and behavioral disturbances are among the most prevalent symptoms reported by women with menstrual disorders.
Psychologic and behavioral symptoms which have been suggested to occur during menstruation include, for example, poorer work or school performance, increased napping and time in bed, increased time at home, avoiding social activities, decreased efficiency, insomnia, forgetfulness, confusion, poorer judgement, difficulty concentrating, distractibility, increased accidents, poorer motor coordination, crying, loneliness, anxiety, restlessness, irritability, mood swings, depression, and tension. The effect of these symptoms can be compounded by physical menstrual symptoms such as, for example, dizziness, faintness, cold sweats, nausea, vomiting, hot flashes, muscle stiffness, headache, cramps, backache, fatigue, general aches and pains, and water retention including, for example, weight gain, skin disorders, painful breasts, and swelling. [See, e.g., Penland, J. G., et al., Am. J. Obstet. Gynecol. 168 (5) :1417-1423 (1993)]. Collectively, these and other known symptoms of menstruation are herein referred to as menstrual symptoms.
Numerous treatments have been suggested for alleviating or minimizing menstrual symptoms. These include, for example, variation in total energy intake and consumption of protein, fat, carbohydrates, vitamins B and E, magnesium, zinc, calcium, manganese, and fatty acids, such as linolenic acid (primrose oil) [see, e.g., Penland, J. G., et al. supra]. Other treatments include the administration of an analgesic/anti-inflammatory agent such as ibuprofen in combination with a diuretic agent and, optionally, an antihistamine such as pyrilamine maleate (see, e.g. U.S. Pat. No. 4,888,343).
Although these and other treatments are available, a multitude of women continue to suffer one or more menstrual symptoms on a monthly basis. Accordingly, the present invention provides methods for alleviating one or more menstrual symptoms in women, and compositions therefore.